fesoterodine fumarate
Drug Details
- Generic Name
- fesoterodine fumarate
- Brand Names
- fesoterodine fumarate, Toviaz
- Application Number
- ANDA204946
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 6
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- FESOTERODINE FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.